D-0984-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 26, 2017
- Initiation Date
- June 29, 2017
- Termination Date
- April 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 196275 bottles
Product Description
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 30227649A ,30227650A, 30227651A, 30227652A, 30227653A, 30227654A, 30227655A, 30227832A, 30227833A, 30227834A, 30227835A, EXP 06/2017; 30228561A, 30228562A, 30228563A, 30228564A, 30228565A, 30228566A, 30228567A, 30228568A, 30228569A, 30228570A, EXP 9/2017; 3000124, 3000125, EXP 7/2018; 3000392, 3000393, 3000394, EXP 9/2018; 3000872, 3000874, EXP 10/2018;